Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
General requirements concerning packaging and labelling
1. Written procedures shall be put in place to describe the receipt, identification, quarantine, sampling, examination or testing, release, and handling of packaging and labelling materials. 2. Packaging and labelling materials shall conform to established specifications. Packaging and labelling materials that do not comply with the specifications shall be rejected to avoid their use in operations for which they are unsuitable.
Containers
1. Containers shall provide adequate protection against deterioration or contamination of the active substances or intermediates thereof that may occur during transportation and storage. 2. Containers shall be clean and, where indicated by the nature of the active substances or intermediates thereof, sanitised to ensure that they are suitable for their intended use. Those containers shall not be reactive, additive, or absorptive so as to alter the quality of the active substances or intermediates thereof beyond the specified limits. 3. Whenever containers are re-used, they shall be cleaned in accordance with documented procedures and all previous labels shall be removed or defaced.
Label issuance and control
1. Access to the areas where labels are stored shall be limited to authorised personnel. 2. Procedures shall be used to reconcile the quantities of labels issued, used and returned, and to identify discrepancies between the number of containers labelled and the number of labels issued. Such discrepancies shall be investigated, and the investigation shall be approved by the quality unit. 3. All excess labels bearing batch numbers or other batch-related printing shall be destroyed. Returned labels shall be maintained and stored in a manner that provides proper identification and prevents mix-ups of labels. 4. Obsolete and outdated labels shall be destroyed, and such disposal be recorded. 5. Printing devices used to print labels for packaging operations shall be controlled to ensure that all imprinting conforms to the print specified in the batch production record. 6. Printed labels issued for a batch shall be carefully examined for proper identity and conformity with specifications in the master production record. The results of this examination shall be documented. 7. A printed label as used for the batch concerned shall be included in the batch production record.
Packaging and labelling operations
1. Documented procedures shall be put in place to ensure that correct packaging materials and labels are used. 2. Appropriate measures shall be implemented to avoid mix ups of packaging materials or labels. There shall be physical or spatial separation from operations involving other intermediates or active substances. 3. Labels used on containers of intermediates or active substances shall indicate the name or identifying code, the batch number of the product, and storage conditions, when that information is critical to assure the quality of the active substance or intermediates thereof. 4. Whenever the intermediate or the active substance is intended to be transferred outside the control of the manufacturer, the label shall also include the name and address of the manufacturer, quantity of contents, special transport conditions and any special legal requirements. For intermediates or active substances with an expiry date, the expiry date shall be indicated on the label and on the certificate of analysis. For intermediates or active substances with a retest date, the retest date shall be indicated on the label and on the certificate of analysis. 5. Packaging and labelling premises shall be inspected immediately before use to ensure that all materials not needed for the next packaging operation have been removed. This inspection shall be documented in the batch production records, the facility log, or other documentation system. 6. Packaged and labelled intermediates or active substances shall be examined to ensure that containers and packages in the batch have the correct label. That examination shall be part of the packaging operation. Results of those examinations shall be recorded in the batch production or control records. 7. Intermediate or active substance containers that are transported outside of the manufacturer's control shall be sealed in a manner such that, if the seal is breached or missing, the recipient will be alerted to the possibility that the contents may have been altered.
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.